Efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain: A study protocol for a randomized, controlled, assessor-blinded, multicenter clinical trial.
Study Goal
The researchers aimed to evaluate the efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain.
Results Summary
The study protocol outlines a rigorous trial design to assess the effectiveness of thread embedding acupuncture alongside conventional acupuncture, with primary outcomes focusing on pain reduction and secondary measures including quality of life and disability levels. Results are pending, but the study aims to provide evidence for this combined treatment approach.
Population
38 outpatients with chronic low back pain recruited from 4 traditional Korean Medicine hospitals.
Effective Dosage
Thread embedding acupuncture at 10 points once weekly; conventional acupuncture at 14 points twice weekly.
Duration
8 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
thread embedding acupuncture combined with conventional acupuncture | neutral | chronic low back pain | outpatients with chronic low back pain | - | will provide evidence of the efficacy and safety | #1 |
thread embedding acupuncture combined with conventional acupuncture | neutral | visual analog scale score | outpatients with chronic low back pain | - | will be compared | #2 |
thread embedding acupuncture combined with conventional acupuncture | neutral | clinical relevance (minimal clinically important difference) | outpatients with chronic low back pain | - | will be compared | #3 |
thread embedding acupuncture combined with conventional acupuncture | neutral | quality of life (3-level version of Euroqol-5D) | outpatients with chronic low back pain | - | will be compared | #4 |
thread embedding acupuncture combined with conventional acupuncture | neutral | disability level (Roland and Morris Disability Questionnaire) | outpatients with chronic low back pain | - | will be compared | #5 |
thread embedding acupuncture combined with conventional acupuncture | neutral | global assessment (patient global impression of change) | outpatients with chronic low back pain | - | will be compared | #6 |
thread embedding acupuncture combined with conventional acupuncture | neutral | safety | outpatients with chronic low back pain | - | will be compared | #7 |
BACKGROUND: Back pain is one of the most common diseases, and many patients with recurrent pain seek alternative treatment strategies. Thread embedding acupuncture involves thread insertion at the acupuncture point for continuous physical and chemical stimulation. Although thread embedding is widely used in clinical practice, there is no sound evidence of its efficacy for chronic back pain. We describe the protocol for a randomized controlled trial for investigation of the efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain. METHODS: This randomized, controlled, assessor-blinded, 2-armed, parallel, multicenter clinical trial will include 38 outpatients with chronic low back pain recruited from 4 traditional Korean Medicine hospitals. The patients will be randomly allocated to a treatment group (conventional acupuncture + thread embedding acupuncture) and a control group (only conventional acupuncture) in a 1:1 ratio. The treatment group patients will receive thread embedding acupuncture treatment at 10 acupuncture points (multifidus muscle, 4 points; spinal erector muscles, four points; lumbar quadrate muscle, 2 points) once a week for 8 weeks (8 sessions). In addition, all patients will receive conventional acupuncture treatment at 14 acupuncture points (GV3, EX-B5, and bilateral BL23, BL24, BL25, BL26, BL40, and BL60) twice a week for 8 weeks (16 sessions). The primary outcome will be the change in the visual analog scale score from visit 1 to visit 16, analyzed by independent t tests, in both groups. The groups will also be compared with regard to the clinical relevance (minimal clinically important difference), quality of life (3-level version of Euroqol-5D), disability level (Roland and Morris Disability Questionnaire), global assessment (patient global impression of change), and safety. Cost data for cost-benefit and cost-effectiveness analyses will be collected. DISCUSSION: Our study results will provide evidence of the efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for the management of chronic low back pain. Even though the assessors will be blinded, the patients will not be blinded to treatment because of the lack of a sham embedding acupuncture group; this is a limitation of our study. TRIAL REGISTRATION: Clinical Research Information Service: KCT0002666.